[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended
Exhibit 10.1
Change Order Form
Change Order No.: 2
Change Order Submission Date:10 March 2015
Sponsor: ARCA biopharma Inc. (“Sponsor”)
Study Drug/Protocol No.: BUC-CLIN-303
Study Title: GENETIC-AF (“Study”)
EPM#: 5969
SPS#: 200267
Sponsor Contact:
[*]
DCRI Contacts:
Project Leader:
[*]
Business Development:
[*]
Sponsor and Duke University (“Duke” or “DCRI”) entered in a Clinical Research Agreement (the “Agreement”), effective 05 November 2013, to conduct the above-referenced Project and Change Order No. 1 was executed November 2014. This Change Order No. 2 serves as an amendment to the Agreement and provides details related to scope changes and associated budget adjustments.
Description of Scope Changes: The budget for this Change Order No. 2 is detailed in Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate,” and an explanation of the change is referenced in the column called “Justification for Revised Scope”. Unless otherwise noted, the unit costs remain the same.
Study Timeline
There are no changes to the timeline.
Description of Budget Change Summary:
Type | Contract Value through Change Order No. 1 | Change Order No. 2 Value | Revised Total |
DCRI Direct Fees | [*] | [*] | [*] |
Pass-through Costs | [*] | - | [*] |
Total | [*] | [*] | [*] |
See attached budget file.
The DCRI will invoice completed units on a monthly basis. All payments remain as agreed upon as in the Agreement unless otherwise stated.
Approval Signature:
Sponsor:
By: /s/ Michael Bristow Title: President / CEO – ARCA Date: March 10, 2015 | Duke University:
By: /s/ David S. Hill Title: Assistant Director, Finance – DCRI Date: March 13, 2015
|
[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended
Attachment 1
DCRI Detailed Fees and Pass-through Cost Estimate
[* 3 pages of text omitted]
[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended